Diamyd Medical has contracted the global contract research company (CRO) TFS Trial Form Support International for the conduction of DIAGNODE-2, a clinical trial in children and young adults recently diagnosed with type 1 diabetes. The placebo-controlled Phase II trial is a pivotal follow-up trial with an innovative and patent-pending concept where the diabetes vaccine Diamyd® is administered directly into the lymph node. The trial is expected to start recruiting patients this fall.

”We are very pleased to have TFS as our partner for this decisive trial with our diabetes vaccine”, says Ulf Hannelius, President and CEO of Diamyd Medical. “Their extensive experience of conducting multinational clinical studies in diabetes is of course valuable and our highest mutual priority is now to advance the DIAGNODE-2 trial as efficiently and quickly as possible.”

DIAGNODE-2 will be conducted at a number of selected clinics in some countries in Europe including Sweden. The trial includes approximately 80 patients aged 12-24 years, recently diagnosed with type 1 diabetes, and the patients will be followed for 15 months. The aim of the trial is to evaluate the effect of the treatment in preserving the patients' insulin producing capacity. The Coordinating Investigator for the trial is Professor Johnny Ludvigsson at Linköping University.

The process of having the trial approved by the Competent Authorities and Ethics Committees in each country is underway and the trial is expected to start in the fall of 2017.

The decision to conduct the trial is based on highly promising preliminary clinical results from the ongoing open-label DIAGNODE-1 trial in which children and adolescents recently diagnosed with type 1 diabetes are given Diamyd® directly into the lymph node. The clinical effect of preserving the patient’s own insulin production is estimated to be significantly improved when the diabetes vaccine Diamyd® is administered directly into the lymph node, as compared to injecting it under the skin as in previous Phase III trials. The Diamyd Medical patent pending concept can be compared to the development of allergy treatment where it has been found that the administration of allergen into the lymph node significantly improves the treatment effect.

About Diamyd MedicalDiamyd Medical is dedicated to finding a cure for diabetes and other serious inflammatory diseases through pharmaceutical development and investments in stem cell and medical technology.

Diamyd Medical develops the diabetes vaccine Diamyd®, an antigen-specific immunotherapy based on the exclusively licensed GAD-molecule. Five clinical trials are ongoing with Diamyd®. An exclusive license comprising the therapeutic use of GABA in diabetes and inflammatory diseases constitutes alongside with the diabetes vaccine a key asset and the Company is developing a proprietary GABA drug product. Diamyd Medical is one of the major shareholders in the stem cell company NextCell Pharma AB and has holdings in the medtech company Companion Medical, Inc., San Diego, USA and in the gene therapy company Periphagen, Inc., Pittsburgh, USA.

Diamyd Medical’s B-share is traded on Nasdaq First North under the ticker DMYD B. FNCA Sweden AB is the Company’s Certified Adviser. Further information is available on the Company’s website: www.diamyd.com.

This information is information that Diamyd Medical AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08:30 CET on April 21, 2017.